Draft Rules On e – Pharmacies: Not the Right Prescription
The increasing popularity of e-commerce, including e-pharmacies, is undeniable. E-pharmacies offer the comfort of shopping from home, privacy, and price discounts. It also allows access to drugs, not available locally.
However, risks exist in buying drugs online. Supply of fake and illegal drugs; abuse on account of fake or forged or no prescriptions; lack of verification of the ultimate user; unhealthy competition; abuse of critical health data generated online; and mishandling during transport; are some of them.
In India, in the absence of any legislative framework, existence of e – pharmacies is per-se illegal. The Drugs Controller General of India (DCGI) banned sale through e – pharmacies on 30th December, 2015. Yet, e-pharmacies have grown rapidly as against the traditional “brick-and-mortar” or offline pharmacies.
Difference between e-commerce and e-pharmacy:
Drugs are different from FMCG. They are supposed to be dispensed with and used for specific ailment only as per medical advise. Indiscriminate availability and reckless usage leads to habit forming tendencies. Overuse of antibiotics is leading to resistance to medicines, the persistence of infections and treatment failure. There is a larger public interest in regulating supply and use of drugs.
Sale of spurious or substandard drugs results in health problems or even death. The manufacturing, stocking, distribution and sale of medicines by offline pharmacies is heavily regulated. Such is not the case for goods available on normal e-commerce websites.
Also, the data shared online for drugs purchase needs to be strictly protected. European Union’s General Data Protection Regulation (GDPR) treats “data concerning health” as a special category of personal data. Similar is the recommedation by the Justice Srikrishna Committee in its report on “Data protection and Privacy.”
Draft Rules for E-pharmacy:
The Central Government has recently notified Draft Rules for amending the Drugs and Cosmetics Rules, 1945. New provisions for “Sale of Drugs by E – pharmacy” have been proposed.
The timing of the Draft Rules is, however, questionable. The policy for “Electronic Commerce in India” is in draft stage, having being circulated last month. Likewise, the law on data protection is still being deliberated. E – Pharmacies would be bound by the norms laid down for “electronic commerce.” Ideally, till the norms for e-commerce are not finalised, law for e-pharmacies would continue to be in a flux.
Requirement for Prescription for Sale:
According to the draft rules, an e-pharmacy is not permitted without a registration certificate from a Central Licensing Authority to distribute and sell, stock or exhibit or offer for sale, drugs. The e-pharmacy holder can receive orders only for retail sale through its portal.
Once the prescription is received, the registered pharmacist on behalf of the e-pharmacy is required to verify the details of patient, registered medical practitioner and arrange for dispensation. “Prescription” has to be an instruction from Registered Medical Practitioner to a patient, written in hand or in any electronic mode.
This definition of “prescription” is vague. A digitally signed prescription from the Doctor only or a directly communication by the Doctor to an e-pharmacy is not mandated. A scanned document is sufficient. An old prescription or a fabricated prescription could still be used to buy drugs. Currently, several e – pharmacies supply even on fake prescriptions. The rules do not lay down any modalities for verification.
For example, in the U.K., a clinic started to help teenagers addicted to prescription drugs bought illegally on the web saw people in mid – 20s and 30s instead being enrolled. Such individuals got addicted to prescription drugs by buying them online, even after being refused further usage by their General Physician. An investigation by “The Guardian” found that online pharmacies had no alert system in place to identify multiple orders to the same address.
This is in stark contrast to the recommendations by a “Sub – Committee” constituted by the Drugs Consultative Committee under the DGCI in 2016 for creation of a national portal, operating as nodal platform for transacting and monitoring online sale of drugs. It also recommended online sale of drugs on the basis of an electronically generated and digitally signed prescription to prevent misuse by multiple use of same prescription and fake/forged prescriptions.
Section 3 of the Information Technology Act, 2000, requires authentication of electronic records only by affixing digital signature. Electronic Health Record (EHR) Standards, 2016 issued by Ministry of Health, also state that it must be ensured that e-prescription is digitally signed by a registered medical practitioner. In the U.S., the Verified Internet Pharmacy Practice Sites (VIPPS) does not allow a pharmacy to dispense drugs based upon telephonic, electronic or online medical consultations. Such stipulations are absent in the Draft Rules.
According to the Draft Rules, a prescription generated by the e – phamracy, through its own panel of doctors would also be valid. Many e – pharmacies already offer the same. The clear conflict of interest on the role of the doctor has been overlooked in the Draft Rules. As per the MCI, a doctor’s prescription has to be prepared only after physical consultation and examination. In the U.S., a prescription has to be issued either by a practitioner who has conducted at least one in-person medical evaluation of the patient or by a covering practitioner.
An equally crucial issue is the availability of Schedule H and H 1 Drugs of Drugs and Cosmetics Rules, 1945 through e-pharmacies, while drugs under the NDPS Act, tranquilizers and Schedule X drugs have been prohibited. The prohibition of certain drugs is an implicit acceptance of serious challenges in online sale of drugs. Schedule H and H 1 drugs also fall under the category of the prescription drugs and are equally harmful if not taken as per subscription and under proper supervision.
Apart from the above, issue of pricing and advertising vis – a – vis offline pharmacies and privacy of consumers are also critical and need to be properly addressed by the Rules.
Technology is evolving at an exponential pace and generally law always has to catch up. It needs to do so for e – pharmacies in India as well. The diagnosis of the problems with e – pharmacies in India is not correct. So is the prescription in the form of Draft Rules. A more robust regime is essential to take care of interests of all stakeholders, specially, in the sensitive area of health care and accessibility of drugs.Advocate Amit Gupta is an Oxford and Columbia graduate and based in New Delhi
[The opinions expressed in this article are the personal opinions of the author. The facts and opinions appearing in the article do not reflect the views of LiveLaw and LiveLaw does not assume any responsibility or liability for the same]